MLN8237 for a Subject With Adenocarcinoma of the Prostate

• Conditions: Prostate Cancer

• Registration Number: NCT03005262
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

To allow a patient continued access to MLN8237

Detailed Description

Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate

Study Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-29
• Status Verified: 2018-02
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• 18 years or older
• Histologically or cytologically confirmed advanced tumors and candidates for docetaxel treatment
• Measurable or evaluable disease is required. Patients must have clinical evidence of progressive disease or persistent disease
• Patients with castration-resistant prostate cancer (CRPC) are required to have
• Pathologically confirmed adenocarcinoma of the prostate
• Evidence of metastatic disease on bone scan or other imaging. Patients with PSA elevation as the only manifestation of disease are not eligible.
• Progressive disease after at least 1 hormonal treatment with documented testosterone levels less than 50 ng/dl
• Concurrent use of an agent for testosterone suppression (e.g., LHRH agonist) is required if the patient has not been surgically castrated
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Recovered to less than or equal to Grade 1 toxicity (CTCAE), to patient's baseline status (except alopecia) or deemed irreversible from the effects of prior cancer therapy and must have evidence of progressive or persistent disease
• Adequate bone marrow, liver and renal function
• Any use of opiates must be stable for at least 2 weeks prior to study entry
• Male patients who agree to practice effective barrier contraception during the entire study and through 6 months after the last dose of study drug OR agree to abstain from heterosexual intercourse
• Voluntary written consent
• Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
• Suitable venous access for blood sampling

Exclusion Criteria

• Antineoplastic therapy or any experimental therapy within 21 days before the first dose of MLN8237
• Prior or current investigational therapies within 4 weeks before the first dose of MLN8237
• Radiotherapy to greater than 40% of bone marrow or any radiotherapy (except localized, small field radiation) within 4 weeks prior to enrollment, unless reviewed and approved by the medical monitor
• Nitrosoureas or mitomycin-C within 6 weeks before the first dose of MLN8237.
• Autologous stem cell transplant within 3 months before the first dose of MLN8237, or prior allogeneic stem cell transplant at any time.
• Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237
• For CRPC patients:
• Radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to enrollment
• Prior treatment with antineoplastic chemotherapy or radioisotopes for advanced prostate cancer
• Use of products known to affect PSA levels within 4 weeks of enrollment
• Major surgery within 4 weeks of study enrollment
• Uncontrolled high blood pressure
• Patients with abnormal gastric or bowel function or who require continuous treatment with antacids or proton pump inhibitors
• Patients receiving chronic steroid therapy other than the following: low dose steroid for the control of nausea and vomiting, topical steroid, inhaled steroid or use of dexamethasone
• Known severe hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
• Comorbid condition or unresolved toxicity that would preclude administration of docetaxel
• Prior history of Grade 2 or greater neurotoxicity or any toxicity that has not resolved to Grade 1 or below
• Symptomatic brain or other CNS metastasis
• Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
• Patients requiring full systemic anticoagulation
• Prior allogeneic bone marrow or other organ transplant
• Active infection requiring systemic therapy within 14 days preceding first dose, or other serious infection
• History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months
• Serious medical or psychiatric illness that could interfere with protocol completion
• Inability to swallow oral medication
• Prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
• Prior treatment with more than 1 prior taxane-containing regimen

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified